The FDA approval of Zytiga (abiraterone acetate) for men with advanced prostate cancer defines the men who qualify to receive the drug. To qualify you must have advanced prostate cancer and meet all of the three criteria below: 1- Men who are metastatic. 2- Men who failed hormone therapy also known as castrate resistant or [...]
The long awaited FDA approval of Zytiga (abiraterone acetate), a once-daily oral agent, for the treatment of castration-resistant, metastatic prostate cancer following docetaxel chemotherapy has happened! Malecare celebrates this approval as it celebrates the significant numbers of new drug approvals we have had over the last year and one half. The approval of Zytiga represents [...]
Increasingly it has become obvious to me and to many other individuals that our current drug approval and development process has a basic flaw. If you go to research conferences you quickly learn that there is probably no magic bullet to stop any type of cancer, including advanced prostate cancer. Current drug development focuses on [...]
As we all anxiously wait for the FDA to finally make a determination about the pending application for approval of the investigational androgen biosynthesis inhibitor abiraterone acetate more data rolls in showing that supports the need to have a speedy approval. A new study published March 1, 2011, out of Italy adds support to the [...]
Prostate cancer diets and the use of supplements have continued to be an issue faced by men fighting advanced prostate cancer. Different products seem to fall in and out of vogue; unfortunately we usually have little actual hard data on the real value of any of these products. The use of pomegranate with the goal [...]
It has been announced that the application for the FDA approval of abiraterone with prednisone has been submitted by Centocor Ortho Biotech Inc. As I have discussed in prior posts, abiraterone is an extraordinarily promising investigational drug designed to treat metastatic advanced prostate cancer in men who have received prior chemotherapy containing a taxane. [...]
The investigational drug Abiraterone, designed for the treatment of men with advanced prostate cancer who have failed chemotherapy has not yet been approved by the FDA. Because of the extraordinarily positive results that were obtained on the phase III trials (which were stopped early because of these fantastic results) the pharmaceutical manufacturer of the drug [...]
Applications for the approval of Abiraterone Acetate (Abiraterone) have been submitted to both the U.S. Food and Drug Administration (FDA) and to the European Medicines Agency (EMA). The applications are for the approval of Abiraterone with prednisone for the treatment of metastatic advanced prostate cancer in men who have received prior chemotherapy containing a taxane. [...]
In order to get FDA approval, drugs must first go through a clinical trial that demonstrates that they offer a better treatment result than the current standard of care. In some instances the better result can be a demonstration that the investigational drug provides an advantage which is only palliative (as Mitoxantrone does for advance [...]
Ortho Biotech & Development, a unit of Cougar Biotechnology, Inc. has unblinded their Phase 3 study of abiraterone acetate plus prednisone. In the trial the abiraterone was used for the treatment of men with metastatic advanced prostate cancer has progressed following treatment with one or two chemotherapy regimens at least one of which contained docetaxel. [...]
